| CTRI Number |
CTRI/2023/05/052699 [Registered on: 16/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare vasodilatory effect of desflurane vs sevoflurane using perfusion index as a measure |
|
Scientific Title of Study
|
A comparative study to evaluate vasodilatory effect of Desflurane vs Sevoflurane using Perfusion Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeru Luthra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana PUNJAB 141001 India |
| Phone |
9815500960 |
| Fax |
|
| Email |
drneeru1977@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gunjan Dhawan |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana PUNJAB 141001 India |
| Phone |
7009151875 |
| Fax |
|
| Email |
gunjandhawan024@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gunjan Dhawan |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India
Ludhiana PUNJAB 141001 India |
| Phone |
7009151875 |
| Fax |
|
| Email |
gunjandhawan024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeru Luthra |
Dayanand Medical College and Hospital |
Department of Anaesthesia Dayanand Medical College and Hospital Tagore Nagar Civil Lines Ludhiana 141001 Ludhiana PUNJAB |
9815500960
drneeru1977@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Research and Ethical committee,Dayanand Medical College and Hospital |
Approved |
| Research and ethics committee,Dyanand medical college and hospital,Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sevoflurane
|
Group S will be given anaesthesia using Sevoflurane through inhalational route at one MAC for 20 minutes |
| Intervention |
comparative study to evaluate Vasodilatory effect of Desflurane vs Sevoflurane using Perfusion Index
|
Anaesthesia will be induced using either Desflurane or Sevoflurane depending on Group allocation. |
| Comparator Agent |
Desflurane
|
Group D will be given desflurane through inhalational route at one MAC for 20 minute before incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
sixty adults of either sex, age group (18yr-65yr) belonging to the American Society of Anaesthesiologist (ASA) Physical status I and II adults scheduled for elective surgery under GA |
|
| ExclusionCriteria |
| Details |
1.Receiving any medications that may affect vascular tone (eg vasoactive drugs, such as calcium channel blockers or angiotensin receptor blockers)
2.Cardiovascular or peripheral vascular disease (e.g. Diabetic vasculopathy or Raynaud’s disease)
3.Medications that may affect sympathetic or parasympathetic tone(e.g. beta blockers or anticholinergics)
4.Diabetes mellitus
5.Any neurological or psychiatric diseases, including history of, or treatment for, substance abuse, anxiety, or depression.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perfusion index will be the primary outcome for the study. |
Baseline Perfusion index will be noted and then continuously recorded every minute for 20 min ,after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure.
|
Baseline HR, PI, SBP, DBP and MAP will be noted and then continuously recorded every minute for 20 min ,after induction of anaesthesia.
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sevoflurane and Desflurane are the most commonly used inhalational anaesthetics. These anaesthetics volatile cause dose-dependent effect on cardiovascular function, either through effects on the myocardium itself or by decreasing systemic vascular resistance (SVR) and sympathetic outflow. Perfusion index (PI) can effectively assess peripheral perfusion dynamics and vascular tone. It can be non-invasively and continuously obtained using pulse oximeter. With this background this study has been designed to compare the vasodilatory properties of Desflurane and Sevoflurane.A prospective randomized study will be conducted on 60 patients posted for surgery under general anaesthesia divided into two equal groups. Sevoflurane or Desflurane at 1.0 MAC will be used to maintain anaesthesia as per group allocation. PI will be recorded and compared in both the groups.Clinically, changes in heart rate and blood pressure are most important because, in patients at an increased risk of cardiovascular complications, both hypotension and tachycardia may cause a dramatic increase in the incidence of perioperative adverse events. PI is a novel predictor of changes in peripheral vasomotor tone. Hence, this study will help compare the two inhalational agents and find better agent with minimal perioperative adverse events due to tachycardia and hypotensionClinically,
changes in heart rate and blood pressure are most important because,
in patients at an increased risk of cardiovascular complications, both
hypotension and tachycardia may cause a dramatic increase in the incidence of
perioperative adverse events. PI is a novel predictor of changes in peripheral
vasomotor tone. Hence, this study will help compare the two inhalational agents
and find better agent with minimal perioperative adverse events due to
tachycardia and hypotension. |